Systems And Methods For Treating A Tissue Site With Reduced Pressure Involving A Reduced-Pressure Interface Having A Multi-Lumen Conduit For Contacting A Manifold

ABSTRACT

Systems and methods for a reduced-pressure interface for connecting a multi-lumen conduit to a distribution manifold. The interface includes a housing having a flange portion and a cavity wall portion. The cavity wall portion forms a cavity having a tissue-facing cavity opening. The interface further includes an attachment device, a conduit port, and a multi-lumen conduit. The attachment device is coupled to a tissue-facing side of the flange portion for coupling the housing to a sealing member. The conduit includes a distal end and a proximal whereby the distal end extends through a conduit aperture and past the cavity wall portion into the cavity. The conduit further includes a primary lumen and a plurality of sensing lumens. The primary lumen and the plurality of sensing lumens extend from the proximal end of the conduit to the distal end. The conduit is adapted to contact the distribution manifold.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/657,989, entitled “Systems and Methods for Treating a TissueSite with Reduced Pressure Involving a Reduced-Pressure Interface Havinga Multi-Lumen Conduit for Contacting a Manifold,” filed Jul. 24, 2017,which is a continuation of U.S. patent application Ser. No. 14/678,698,entitled “Systems and Methods for Treating a Tissue Site with ReducedPressure Involving a Reduced-Pressure Interface Having a Multi-LumenConduit for Contacting a Manifold,” filed Apr. 3, 2015, now U.S. Pat.No. 9,750,857, which is a continuation of U.S. patent application Ser.No. 13/554,542, entitled “Systems and Methods for Treating a Tissue Sitewith Reduced Pressure Involving a Reduced-Pressure Interface Having aMulti-Lumen Conduit for Contacting a Manifold,” filed Jul. 20, 2012, nowU.S. Pat. No. 9,023,012, which claims the benefit, under 35 USC §119(e), of the filing of U.S. Provisional Patent Application No.61/511,840, entitled “Systems and Methods for Treating a Tissue Sitewith Reduced Pressure Involving a Reduced-Pressure Interface Having aCutting Element,” filed Jul. 26, 2011, and U.S. Provisional PatentApplication No. 61/511,827, entitled “Systems and Methods for Treating aTissue Site with Reduced Pressure Involving a Reduced-Pressure InterfaceHaving a Multi-Lumen Conduit for Contacting a Manifold,” filed Jul. 26,2011, which is incorporated herein by reference for all purposes.

BACKGROUND

The present disclosure relates generally to medical treatment systemsand, more particularly, but not by way of limitation, to systems,methods, and apparatuses for treating a tissue site with reducedpressure involving a reduced-pressure interface having a multi-lumenconduit for contacting a manifold.

Clinical studies and practice have shown that providing a reducedpressure in proximity to a tissue site augments and accelerates thegrowth of new tissue at the tissue site. The applications of thisphenomenon are numerous, but application of reduced pressure has beenparticularly successful in treating wounds. This treatment (frequentlyreferred to in the medical community as “negative pressure woundtherapy,” “reduced pressure therapy,” or “vacuum therapy”) provides anumber of benefits, which may include faster healing and increasedformulation of granulation tissue. Typically, reduced pressure isapplied to tissue through a manifold device, such as a porous pad. Theporous pad contains cells or pores that distribute reduced pressure tothe tissue and channel fluids that are drawn from the tissue.

SUMMARY

According to an illustrative embodiment a reduced-pressure interface forconnecting a multi-lumen conduit to a distribution manifold ispresented. The reduced-pressure interface includes a multi-lumen conduitthat abuts, at least in part, a distribution manifold. The distributionmanifold contacts at least some distal apertures that open into sensinglumens in the multi-lumen conduit. The distribution manifold may therebyprotect those openings from liquids entering that might block thesensing lumens.

According to another illustrative embodiment, a system for treating atissue site on a patient with reduced pressure includes a distributionmanifold for placing proximate to the tissue site, a sealing member forcovering the distribution manifold and a portion of intact epidermis ofthe patient to form a sealed space, a reduced-pressure interface forproviding reduced pressure through the sealing member to thedistribution manifold, a reduced-pressure source, and a multi-lumenconduit for fluidly coupling the reduced-pressure source to thereduced-pressure interface. The reduced-pressure interface includes ahousing having a cavity wall portion. The cavity wall portion forms acavity having a tissue-facing cavity opening. The reduced-pressureinterface further includes an attachment device coupled to the housingfor coupling the housing to the sealing member, a conduit port coupledto the cavity wall and having a conduit aperture, and a multi-lumenconduit. The multi-lumen conduit has a distal end and a proximal end.The distal end of the multi-lumen conduit extends through the conduitaperture into the cavity. The multi-lumen conduit further includes atleast one primary lumen for delivering reduced pressure and a pluralityof sensing lumens. The primary lumen and the plurality of sensing lumensextend from the distal end of the multi-lumen conduit towards theproximal end of the multi-lumen conduit. The plurality of sensing lumenshave a corresponding plurality of distal openings at the distal end ofthe multi-lumen conduit. At least one of the plurality of distalopenings of the plurality of sensing lumens contacts the distributionmanifold.

The reduced-pressure interface allows the sensing lumens not to becomeblocked. This is because the distribution manifold is against at leastone of the distal apertures and helps protect the sensing lumen fromliquid entry. The reduced-pressure interface may also avoid spraying oran aerosol effect of liquids from the tissue site that might otherwiseenter a sensing lumen.

According to another illustrative embodiment, a method for treating atissue site on a patient with reduced pressure includes disposing adistribution manifold proximate to the tissue site and covering thedistribution manifold and a portion of intact epidermis of the patientwith a sealing member to form a sealed space in which the distributionmanifold is disposed. The sealing member has a first side and a second,tissue-facing side. The method further includes providing areduced-pressure source, providing a multi-lumen conduit having a distalend and a proximal end. The multi-lumen conduit includes a plurality ofsensing lumens and at least one primary lumen. The method furtherincludes fluidly coupling a distal end of the multi-lumen conduit to thesealed space and disposing at least one distal opening of a plurality ofdistal openings of the plurality of sensing lumens in contact with thedistribution manifold. The method also includes delivering reducedpressure to the multi-lumen conduit.

According to another illustrative embodiment, a reduced-pressureconnection for providing reduced pressure to a tissue site in a sealedspace formed by a sealing member includes a distribution manifold forplacing proximate to the tissue site and a multi-lumen conduit. Thedistribution manifold includes a foam member. The multi-lumen conduithas a plurality of sensing lumens and at least one primary lumen. Aplurality of distal opening are associated with the plurality of sensinglumens on a distal end of the multi-lumen conduit. The distal end of themulti-lumen conduit is in direct contact with the distribution manifoldsuch that at least one of the plurality of distal apertures abuts thedistribution manifold.

According to another illustrative embodiment, a reduced pressuretreatment system for treating a wound on a patient with reduced pressureincludes a manifold for positioning adjacent to the wound, a drape forcovering the manifold and a portion of intact epidermis of the patientto form a sealed space, a reduced-pressure interface for providingreduced pressure through the drape to the manifold, a reduced-pressuresource, and a first conduit and a second conduit for fluidly couplingthe reduced-pressure source to the reduced-pressure interface. Thereduced-pressure interface includes a housing having a cavity wallportion that forms a cavity having a tissue-facing cavity opening, anattachment device coupled to the housing for coupling the housing to thedrape, a conduit port coupled to the cavity wall and having a conduitaperture, and the first conduit and the second conduit. The firstconduit and the second conduit have a distal end and a proximal end,such that the distal end extends through the conduit aperture into thecavity. The first conduit further includes at least one primary lumenfor delivering reduced pressure such that the primary lumen extends fromthe distal end to the proximal end of the first conduit. The secondconduit further includes a plurality of sensing lumens extending fromthe distal end to the proximal end of the second conduit. The pluralityof sensing lumens have a corresponding plurality of distal openings atthe distal end of the second conduit, and at least one of the pluralityof distal openings of the plurality of sensing lumens contacts themanifold.

According to yet another illustrative embodiment, a method for treatinga wound on a patient with reduced pressure includes positioning amanifold adjacent to the wound and covering the manifold and a portionof intact epidermis of the patient with a drape to form a sealed space.The drape has a first side and a second, tissue-facing side. The methodfurther includes providing a reduced-pressure source and providing afirst conduit and a second conduit. The first conduit and the secondconduit have a distal end and a proximal end. The second conduit furtherincludes a plurality of sensing lumens. The first conduit furtherincludes at least one reduced-pressure lumen. The method furtherincludes fluidly coupling the distal end of the first conduit and thesecond conduit to the drape, disposing at least one distal opening of aplurality of distal openings of the plurality of sensing lumens incontact with the manifold, and delivering reduced pressure to the firstconduit.

According to another illustrative embodiment, a reduced-pressureconnection for providing reduced pressure to a wound in a sealed spaceformed by a drape includes a manifold for placing proximate to thewound. The manifold includes a foam member. The connection furtherincludes a first conduit having at least one primary lumen such that thefirst conduit has a distal end and a second conduit having a pluralityof sensing lumens such that a plurality of distal opening are associatedwith the plurality of sensing lumens on a distal end of the secondconduit. The distal end of the first and second conduits are in directcontact with the manifold such that at least one of the plurality ofdistal apertures abuts the manifold.

Other features and advantages of the illustrative embodiments willbecome apparent with reference to the drawings and detailed descriptionthat follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic perspective view of an illustrative embodiment ofa system for treating a tissue site with reduced pressure;

FIG. 2 is a schematic, cross-sectional view of an illustrativeembodiment of a multi-lumen conduit of the system shown in FIG. 1 takenalong line 2-2;

FIG. 3A is a schematic, cross-sectional view of an illustrativeembodiment of a reduced-pressure interface having a multi-lumen conduitextending into a cavity of the reduced-pressure interface;

FIG. 3B is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 3A under reduced pressure with a distribution manifoldcontacting the multi-lumen conduit;

FIG. 4 is a schematic, top perspective view of another illustrativeembodiment of a reduced-pressure interface having a multi-lumen conduitextending into a cavity of the reduced-pressure interface;

FIG. 5A is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 4 as applied to a tissue site;

FIG. 5B is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 5A under reduced pressure such that the distributionmanifold contacts the multi-lumen conduit;

FIG. 6 is a schematic, cross-sectional view of one illustrativeembodiment of a reduced-pressure interface having a cutting element foruse as part of a system for treating a tissue site with reducedpressure;

FIG. 7A is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 6 under reduced pressure but prior to the cuttingelement perforating a sealing member;

FIG. 7B is another schematic, cross-sectional view of thereduced-pressure interface of FIG. 6 under reduced pressure after thecutting member has perforated the sealing member;

FIG. 7C is another schematic, cross-sectional view of thereduced-pressure interface of FIG. 6 under reduced pressure after thecutting member has perforated the sealing member and the cutting elementhas been removed;

FIG. 8 is a schematic, cross-sectional view of another illustrativeembodiment of a reduced-pressure interface having a cutting element foruse as part of a system for treating a tissue site with reducedpressure;

FIG. 9A is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 8 being applied on a patient, but prior to reducedpressure being supplied;

FIG. 9B is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 8 under reduced pressure prior to the cutting elementperforating a sealing member; and

FIG. 9C is a schematic, cross-sectional view of the reduced-pressureinterface of FIG. 8 under reduced pressure after the cutting member hasperforated the sealing member and the cutting element has been removed.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of the illustrative embodiments,reference is made to the accompanying drawings that form a part hereof.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is understood thatother embodiments may be utilized and that logical, structural,mechanical, electrical, and chemical changes may be made withoutdeparting from the spirit or scope of the invention. To avoid detail notnecessary to enable those skilled in the art to practice the embodimentsdescribed herein, the description may omit certain information known tothose skilled in the art. The following detailed description is,therefore, not to be taken in a limiting sense, and the scope of theillustrative embodiments are defined only by the appended claims. Unlessotherwise indicated, as used herein, “or” does not require mutualexclusivity.

The term “reduced pressure” as used herein generally refers to apressure less than the ambient pressure at a tissue site that is beingsubjected to treatment. In most cases, this reduced pressure will beless than the atmospheric pressure at which the patient is located.Alternatively, the reduced pressure may be less than a hydrostaticpressure associated with tissue at the tissue site. Unless otherwiseindicated, quantitative values of pressure stated herein are gaugepressures. Reference to increases in reduced pressure typically refer toa decrease in absolute pressure, and decreases in reduced pressuretypically refer to an increase in absolute pressure.

Referring now to the drawings and initially to FIGS. 1-3B, a system 100for treating a tissue site 102 on a patient 104 with reduced pressure ispresented. The system 100 includes a reduced-pressure dressing 106 fordisposing proximate the tissue site 102. The system includes areduced-pressure interface 116 that fluidly couples a multi-lumenconduit 110 to a distribution manifold 112. The reduced-pressureinterface 116 may allow for an easily manufactured connection thatallows at least one of a plurality of sensing lumens 122 within themulti-lumen conduit 110 to remain open or unblocked during operation.During operation, the sensing lumens 122 may remain unblocked by adistal end 118 of the multi-lumen conduit 110 being against (orabutting) or embedded in the distribution manifold 112 such that atleast one distal aperture on the distal end 118 of the multi-lumenconduit 110 is in contact with the distribution manifold 112. This inturn avoids an open area where liquids may spray, foam, or otherwisetravel towards the distal apertures and also offers a filter member infront of the distal apertures.

The system 100 also includes a reduced-pressure treatment unit 108fluidly connected to the reduced-pressure dressing 106 through themulti-lumen conduit 110 for applying reduced pressure to the tissue site102. The reduced-pressure dressing 106 further includes the distributionmanifold 112, a sealing member 114, and the reduced-pressure interface116. The reduced-pressure interface 116 is adapted to connect to themulti-lumen conduit 110. The multi-lumen conduit 110 has the distal end118 and includes at least one primary lumen 120 and the sensing lumens122. While usually there will be only one primary lumen 120, there couldbe additional larger lumens for transporting the reduced pressure to thetissue site 102 and concomitantly removing any fluids. The distal end118 of the multi-lumen conduit 110 is adapted to extend into thereduced-pressure interface 116 and, at least partially, contact thedistribution manifold 112. The multi-lumen conduit 110 may either abutor be embedded within the distribution manifold 112.

Extending the multi-lumen conduit 110 into the reduced-pressureinterface 116 to promote contact between the distal end 118 of themulti-lumen conduit 110 and the distribution manifold 112 may, inaddition to those previously mentioned, provide a number of benefits.The benefits may include ease of application, reduction of error whenforming a seal between the multi-lumen conduit 110 and the distributionmanifold 112, and reduction in instances of sensing lumen occlusion whenfluid is removed from the tissue site 102. Instances where the sensinglumens 122 become occluded may disconnect the system's 100 ability tomonitor levels of reduced pressure, and thus, control the reducedpressure at the tissue site 102.

Fluid removed from the tissue site 102 will follow the path of leastresistance which preferentially is the primary lumen 120. When theprimary lumen 120 and at least one of the sensing lumens 122 are not indirect contact with the manifold, the fluid may splash, foam, orotherwise fail to smoothly transition into the primary lumen 120. Whenthe fluid splashes or foams, the fluid may enter the sensing lumens 122occluding the sensing lumens 122. Should all of the sensing lumens 122become occluded, the sensing lumens 122 are effectively disabled fromsensing the reduced pressure levels at the tissue site 102. When theprimary lumen 120 and at least one of the sensing lumens 122 are incontact with the distribution manifold 112, the fluid withdrawn from thetissue site 102 tends to bypass entering the sensing lumens 122contacting the distribution manifold 112 and flow into the primary lumen120. The distribution manifold 112 may further provide a barrier betweenthe primary lumen 120 and the at least one of the plurality of sensinglumens 122 contacting the distribution manifold 112. Additionally,having the multi-lumen conduit 110 in direct contact with thedistribution manifold 112 may help ensure that there is a constant lowvelocity liquid flow into the multi-lumen conduit 110 which may minimizethe instance of aerosolized particles being deposited around the atleast one sensing lumen 122 contacting the distribution manifold 112 andmay also provide a filter to liquids entering the at least one sensinglumen 122.

In prior reduced pressure treatment systems using a reduced pressureinterface and a multi-lumen conduit, the reduced pressure interfaceshave been designed to remove the sensory lumens from direct contact withthe distribution manifold to inhibit fluid from occluding the sensorylumens. However, testing has shown that removing the sensory lumens fromcontacting the distribution manifold creates splashing and foaming thatmay occlude the sensory lumens undermining the purpose of removing thesensory lumens from contacting the distribution manifold.

The system 100 may be used with various different types of tissue sites102. The tissue site 102 may be a wound 124 or wound cavity. As shown inat least FIGS. 3A-3B, the tissue site 102 or the wound 124, may bethrough an epidermis 126 and into a subcutaneous tissue or any othertissue. The tissue site 102 may be the bodily tissue of any human,animal, or other organism, including bone tissue, adipose tissue, muscletissue, dermal tissue, vascular tissue, connective tissue, cartilage,tendons, ligaments, body cavity or any other tissue. Treatment of thetissue site 102 may include removal of fluids, e.g., exudate or ascites.

Referring still to FIGS. 1-3B, the distribution manifold 112 isproximate the tissue site 102 and has a first side 128 and a second,tissue-facing side 130. The term “distribution manifold” as used hereingenerally refers to a substance or structure that is provided to assistin applying reduced pressure to, delivering fluids to, or removingfluids from the tissue site 102. The distribution manifold 112 typicallyincludes a plurality of flow channels or pathways that distribute fluidsprovided to and removed from the tissue site 102 around the distributionmanifold 112. In one illustrative embodiment, the flow channels orpathways are interconnected to improve distribution of fluids providedor removed from the tissue site 102. The distribution manifold 112 maybe a biocompatible material that is capable of being placed in contactwith the tissue site 102 and distributing reduced pressure to the tissuesite 102. Examples of the distribution manifold 112 may include, withoutlimitation, devices that have structural elements arranged to form flowchannels, such as, for example, cellular foam, open-cell foam, poroustissue collections, liquids, gels, and foams that include, or cure toinclude, flow channels. The distribution manifold 112 may be porous andmay be made from foam, gauze, felted mat, or any other material suitedto a particular biological application. In one embodiment, thedistribution manifold 112 is a porous foam and includes a plurality ofinterconnected cells or pores that act as flow channels. The porous foammay be a polyurethane, open-cell, reticulated foam such as GranuFoam®material manufactured by Kinetic Concepts, Incorporated of San Antonio,Tex. In some situations, the distribution manifold 112 may also be usedto distribute fluids such as medications, antibacterials, growthfactors, and various solutions to the tissue site 102. Other layers maybe included in or on the distribution manifold 112, such as absorptivematerials, wicking materials, hydrophobic materials, and hydrophilicmaterials.

In one illustrative embodiment, the distribution manifold 112 may beconstructed from bioresorbable materials that do not have to be removedfrom a patient's body following use of the system 100. Suitablebioresorbable materials may include, without limitation, a polymericblend of polylactic acid (PLA) and polyglycolic acid (PGA). Thepolymeric blend may also include without limitation polycarbonates,polyfumarates, and capralactones. The distribution manifold 112 mayfurther serve as a scaffold for new cell-growth, or a scaffold materialmay be used in conjunction with the distribution manifold 112 to promotecell-growth. A scaffold is a substance or structure used to enhance orpromote the growth of cells or formation of tissue, such as athree-dimensional porous structure that provides a template for cellgrowth. Illustrative examples of scaffold materials include calciumphosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, orprocessed allograft materials.

The distribution manifold 112 may be covered by the sealing member 114,which may also be referred to as a drape. The sealing member 114 forms asealed space 132 over the tissue site 102. The sealing member 114 has afirst side 134, and a second, tissue-facing side 136. The sealing member114 may be any material that provides a fluid seal. “Fluid seal,” or“seal,” means a seal adequate to maintain reduced pressure at a desiredsite given the particular reduced-pressure source or subsystem involved.The sealing member 114 may, for example, be an impermeable orsemi-permeable, elastomeric material. “Elastomeric” means having theproperties of an elastomer. Elastomer generally refers to a polymericmaterial that has rubber-like properties. More specifically, mostelastomers have ultimate elongations greater than 100% and a significantamount of resilience. The resilience of a material refers to thematerial's ability to recover from an elastic deformation. Elastomersthat are relatively less resilient may also be used as these elastomersare more likely to tear when faced with the cutting element. Examples ofelastomers may include, but are not limited to, natural rubbers,polyisoprene, styrene butadiene rubber, chloroprene rubber,polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber,ethylene propylene diene monomer, chlorosulfonated polyethylene,polysulfide rubber, polyurethane (PU), EVA film, co-polyester, andsilicones. Additional, specific examples of dressing sealing membermaterials include a silicone drape, 3M Tegaderm® drape, polyurethane(PU) drape such as one available from Avery Dennison Corporation ofPasadena, Calif. An additional, specific non-limiting example of adressing sealing member material includes a 30 μm matt polyurethane filmsuch as the Inspire™ 2317 manufactured by Exopack™ Advanced Coatings ofMatthews, N.C. The sealing member 114 may be preformed with an apertureor other means to transmit fluid from the distribution manifold to thereduced-pressure treatment unit 108. Alternatively, a healthcareprovider may cut the sealing member to form an aperture or a cuttingelement attached to a reduced-pressure interface may be used to form anaperture.

An attachment device 138 may be used to hold the sealing member 114against a portion of the patient's intact epidermis 126 or anotherlayer, such as a gasket or additional sealing member. The attachmentdevice 138 may take numerous forms. For example, the attachment device138 may be a medically acceptable adhesive, such as a pressure-sensitiveadhesive, that extends about a periphery or all of the sealing member114. The attachment device 138 may also be a sealing ring or otherdevice. The attachment device 138 is disposed on the second,tissue-facing side 136 of the sealing member 114. Before use, theattachment device 138 may be covered by a release liner (not shown).

The reduced-pressure interface 116 may be positioned adjacent to orcoupled to the sealing member 114 to provide fluid access to thedistribution manifold 112. Another attachment device 152 similar to theattachment device 138 may be used to hold the reduced-pressure interface116 against the sealing member 114. The multi-lumen conduit 110 fluidlycouples the reduced-pressure treatment unit 108 and the reduced-pressureinterface 116. The reduced-pressure interface 116 allows the reducedpressure to be delivered to the tissue site 102. While the amount andnature of reduced pressure applied to a tissue site will typically varyaccording to the application, the reduced pressure will typically bebetween −5 mm Hg (−667 Pa) and −500 mm Hg (−66.7 kPa) and more typicallybetween −75 mm Hg (−9.9 kPa) and −300 mm Hg (−39.9 kPa). For example,and not by way of limitation, the pressure may be −12, −12.5, −13, −14,−14.5, −15, −15.5, −16, −16.5, −17, −17.5, −18, −18.5, −19, −19.5, −20,−20.5, −21, −21.5, −22, −22.5, −23, −23.5, −24, −24.5, −25, −25.5, −26,−26.5 kPa or another pressure.

As shown, the multi-lumen conduit 110 includes the primary lumen 120 andthe plurality of sensing lumens 122. In one illustrative embodiment, theprimary lumen 120 is a central lumen 140 and the plurality of sensinglumens 122 are peripheral lumens 142. The primary lumen 120 and theplurality of sensing lumens 122 are adapted to maintain fluid isolationbetween the primary lumen 120 and the plurality of sensing lumens 122 asthe multi-lumen conduit 110 transports fluids from the reduced-pressureinterface 116 to the reduced-pressure treatment unit 108. Liquids orexudates communicated from the distribution manifold 112 through theprimary lumen 120 are removed from the multi-lumen conduit 110 andretained within a liquid-collection chamber (not explicitly shown) influid communication with the reduced-pressure treatment unit 108. Theplurality of sensing lumens 122 fluidly communicates reduced pressurerepresentative of the tissue site 102 to an instrumentation unit 144.

The reduced-pressure treatment unit 108 may include a liquid-collectionchamber, or a collection canister, and the instrumentation unit 144 influid communication with a reduced-pressure source 146. Theinstrumentation unit 144 may include a microprocessor 148 adapted toprocess pressure signals received by the multi-lumen conduit 110,monitor the pressure signals, and issue alerts according to apre-determined pressure configuration.

In an illustrative embodiment, the reduced-pressure source 146 is anelectrically-driven vacuum pump. In another implementation, thereduced-pressure source 146 may instead be a manually-actuated ormanually-charged pump that does not require electrical power. Thereduced-pressure source 146 instead may be any other type of reducedpressure pump, or alternatively a wall suction port such as thoseavailable in hospitals and other medical facilities. Thereduced-pressure source 146 may be housed within or used in conjunctionwith the reduced-pressure treatment unit 108, which may also include theinstrumentation unit 144. The instrumentation unit 144 may includesensors, processing units, alarm indicators, memory, databases,software, display units, and user interfaces that further facilitate theapplication of reduced pressure treatment to the tissue site 102.

In one example, pressure-detection sensors (not shown) located in theinstrumentation unit 144 may be disposed at or near the reduced-pressuresource 146. The pressure-detection sensors may receive pressure data, ora pressure signal, from the reduced-pressure interface 116 via at leastone of the plurality of sensing lumens 122 that is dedicated todelivering reduced pressure data to the pressure-detection sensors. Thepressure signal or data may be representative of a pressure at a distalend 150 of any one of the plurality of sensing lumens 122. Thepressure-detection sensors may communicate with a processing unit thatmonitors and controls the reduced pressure that is delivered by thereduced-pressure source 146.

Referring now primarily to FIG. 3A-3B, an illustrative embodiment of thereduced pressure interface 116 is presented in more detail. Thereduced-pressure interface 116 includes a housing 154, a conduit port156 coupled to the housing 154, the attachment device 152 for couplingthe reduced-pressure interface 116 to the sealing member 114, and themulti-lumen conduit 110.

The housing 154 may have a flange portion 160 and a cavity wall portion162. The cavity wall portion 162 forms a cavity 164 having atissue-facing cavity opening 166. The conduit port 156 is coupled to orformed as part of the cavity wall portion 162 of the housing 154. Theconduit port 156 includes a conduit aperture 168 whereby the conduitport 156 is adapted to receive the multi-lumen conduit 110. Theattachment device 152 may be coupled to a tissue-facing side 170 of theflange portion 160 for coupling the housing 154 to the first side 134 ofthe sealing member 114. The housing 154 is made of a semi-rigid materialthat is capable of collapsing under a force such as a driving force 172.In a non-limiting example, the reduced-pressure interface 116, and thusthe housing 154, may be made from a plasticized polyvinyl chloride(PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplasticelastomer, poly acrylic, silicone polymer, and polyether block amidecopolymer.

The multi-lumen conduit 110 includes the distal end 118 and a proximalend 158. The distal end 118 extends through the conduit aperture 168 andpast the cavity wall portion 162 into the cavity 164. In one specific,non-limiting embodiment, the distal end 118 extends past the cavity wallportion 162 up to 5 mm. It should be understood, however, that thedistal end 1118 may extend past the cavity wall portion 162 beyond 5 mm.The extent to which the distal end 118 extends past the cavity wallportion 162 may be determined based on the housing's 154 ability tocollapse under the driving force 172. The proximal end 158 of themulti-lumen conduit 110 connects to the reduced-pressure treatment unit108. In one embodiment, the multi-lumen conduit 110 is connected to theconduit port 156. The multi-lumen conduit 110 may be connected to theconduit port 156 by a weld or adhesive. While the multi-lumen conduit110 is shown as extending past the cavity wall portion 162, themulti-lumen conduit 110 may be flush with the cavity wall portion 162(not shown). The multi-lumen conduit 110 is adapted for at least aportion of the distal end 118 of the multi-lumen conduit 110 to contactthe distribution manifold 112 during reduced pressure therapy. In oneembodiment, a distal aperture 174 of the primary lumen 120 and a distalaperture 176 of at least one of the plurality of sensing lumens 122 isadapted to contact the distribution manifold 112.

In operation, a method for treating the tissue site 102 on the patient104 with reduced pressure includes disposing the distribution manifold112 proximate to the tissue site 102. The distribution manifold 112 andthe portion of intact epidermis 126 of the patient 104 is covered withthe sealing member 114 to form the sealed space 132 in which thedistribution manifold 112 is disposed. The sealing member 114 has thefirst side 134 and the second, tissue-facing side 136. Thereduced-pressure interface 116 is coupled proximate the first side 134of the sealing member 114. The multi-lumen conduit 110 couples thereduced-pressure interface 116 to the reduced-pressure source 146. Thereduced-pressure interface 116 includes the housing 154 having theflange portion 160 and the cavity wall portion 162, such that the cavitywall portion 162 forms the cavity 164 having the tissue-facing cavityopening 166. The attachment device 138 coupled to the tissue-facing side170 of the flange portion 160 of the housing 154 connects the housing154 to the sealing member 114. The reduced-pressure interface 116further includes the conduit port 156 coupled to the cavity wall portion162 having the conduit aperture 168 for receiving and coupling to themulti-lumen conduit 110. The multi-lumen conduit 110 includes the distalend 118 and the proximal end 158. The distal end 118 extends through theconduit aperture 168 and past the cavity wall portion 162 into thecavity 164. The multi-lumen conduit 110 further includes the primarylumen 120 for delivering reduced pressure and the plurality of sensinglumens 122. The primary lumen 120 and the plurality of sensing lumens122 extend from the proximal end 158 of the multi-lumen conduit 110 tothe distal end 118. At least a portion of the distal end 118 of themulti-lumen conduit 110 is positioned in contact with the distributionmanifold 112.

The multi-lumen conduit 110 is connected to the conduit port 156. In oneembodiment, the multi-lumen conduit 110 is welded to the conduit port156 prior to packaging. In another embodiment, the multi-lumen conduit110 is attached to the conduit port 156 by an adhesive.

An aperture is formed in the sealing member 114 for providing fluidcommunication between the housing 154 and the distribution manifold 112.The aperture may be preformed, formed by a healthcare provider, orformed by a cutting element on the reduced-pressure interface 116.

The step of coupling the reduced-pressure interface 116 proximate to thefirst side 134 of the sealing member 114 may include using theattachment device 152 of the reduced-pressure interface 116 to adherethe reduced-pressure interface 116 to the sealing member 114.

The step of positioning at least a portion of the distal end 118 of themulti-lumen conduit 110 in contact with the distribution manifold 112may further include positioning the distal aperture 174 of the primarylumen 120 and the distal aperture 176 of at least one of the pluralityof sensing lumens 122 in contact with the distribution manifold 112. Inone embodiment, the distal aperture 176 of the at least one of theplurality of sensing lumens 122 is positioned below the distal aperture174 of the primary lumen 120 relative to the distribution manifold 112.

In another embodiment, the step of positioning the at least the portionof the distal end 118 of the multi-lumen conduit 110 in contact with thedistribution manifold 112 further includes applying the driving force172 to the reduced-pressure interface 116 of sufficient strength tocause the at least the portion of the distal end 118 of the multi-lumenconduit 110 to contact the distribution manifold 112. The driving force172 may push the multi-lumen conduit 110 into the distribution manifold112. In one embodiment the driving force 172 may pull the distributionmanifold 112 into the multi-lumen conduit 110. In yet anotherembodiment, the driving force 172 may both push the multi-lumen conduit110 into the distribution manifold 112 while pulling the distributionmanifold 112 into the multi-lumen conduit 110.

The step of positioning the at least the portion of the distal end 118of the multi-lumen conduit 110 in contact with the distribution manifold112 may further comprise applying a reduced pressure.

In one embodiment, the step of positioning the at least the portion ofthe distal end 118 of the multi-lumen conduit 110 in contact with thedistribution manifold 112 further comprises applying reduced pressurethrough the reduced-pressure interface 116 to create sufficient reducedpressure in the cavity 164 to pull a portion of the distributionmanifold 112 into the cavity 164 such that the distribution manifold 112abuts the distal aperture 174 of the primary lumen 120.

In another embodiment, the step of positioning the at least the portionof the distal end 118 of the multi-lumen conduit 110 in contact with thedistribution manifold 112 further comprises the step of applying reducedpressure through the reduced-pressure interface 116 to create sufficientreduced pressure in the cavity 164 to push the housing 154 towards thedistribution manifold 112 such that the distal aperture 174 of theprimary lumen 120 and the distal aperture 176 of the at least one of thesensory lumens 122 abuts the distribution manifold 112.

In yet another embodiment, the step of positioning the at least theportion of the distal end 118 of the multi-lumen conduit 110 in contactwith the distribution manifold 112 further comprises manually applyingthe driving force 172 to an exterior of the reduced-pressure interface116.

In one embodiment, the step of applying the driving force 172 to thereduced-pressure interface 116 comprising applying reduced pressure tothe cavity 164 less than the threshold pressure (P_(t)) such that thewall portion collapses driving the multi-lumen conduit 110 into thedistribution manifold 112.

Referring now primarily to FIGS. 4-5B, another illustrative embodimentof a reduced-pressure interface 216 is presented. The reduced-pressureinterface 216 is analogous in many respects to the reduced-pressureinterface of FIGS. 3A-3B. The reduced-pressure interface 216 includes ahousing 254 that may have a flange portion 260 and a cavity wall portion262. The flange portion 260 may be coupled to the sealing member 114 bythe attachment device 152. The cavity wall portion 262 is collapsibleunder reduced pressure. In one embodiment, the cavity wall portion 262is collapsible under manual pressure. The cavity wall portion 262 mayinclude a bellows configuration 290 for permitting the cavity wallportion 262 to collapse when a cavity 264 pressure (P_(c)) inside thecavity 264 is less than a threshold pressure (P_(t)) on an absolutepressure side.

The reduced-pressure interface 216 may further include a conduit adapter292 for receiving the multi-lumen conduit 110 to provide fluidcommunication between the reduced-pressure treatment unit 108 and thetissue site 102. The conduit adapter 292 includes an adapter flange 294.The adapter flange 294 is positioned on an exterior 284 of the cavitywall portion 262. In a specific, non-limiting example, the conduitadapter 292 and the adapter flange 294 may be formed from materials toinclude plasticized polyvinyl chloride (PVC), polyurethane, cyclicolefin copolymer elastomer, thermoplastic elastomer, poly acrylic,silicone polymer, and polyether block amide copolymer.

The multi-lumen conduit 110 is connected to the conduit adapter 292. Ina specific, non-limiting embodiment, the multi-lumen conduit 110 may beconnected to the conduit adapter 292 by a weld or an adhesive. Themulti-lumen conduit 110 extends beyond the conduit adapter 292 into thecavity 264. The reduced-pressure interface 216 is configured to positionthe distal end 118 of the multi-lumen conduit 110 in contact with thedistribution manifold 112.

In one embodiment, reduced pressure applied through the reduced-pressureinterface 216 may create sufficient reduced pressure in the cavity 264to pull a portion of the distribution manifold 112 into the cavity 264and abut the primary lumen 120 of the multi-lumen conduit 110. Inanother embodiment, the distribution manifold 112 may be partiallypulled into the primary lumen 120. The distribution manifold 112 abutsthe distal end 118 of the multi-lumen conduit 110 including the distalaperture 176 of the at least one of the plurality of sensing lumens 122.Allowing the distribution manifold 112 to completely abut the distal end118 of the multi-lumen conduit 110 may help ensure fluid isolationbetween each of the lumens in the multi-lumen conduit 110.

Referring now primarily to FIGS. 6-7C, another illustrative embodimentof a reduced-pressure interface 316 is presented. The reduced-pressureinterface 316 is analogous in many respects to the reduced-pressureinterface of FIGS. 3A-3B. The reduced-pressure interface 316 includes ahousing 354, a conduit port 356 coupled to the housing 354, and theattachment device 152 for coupling the reduced-pressure interface 316 tothe sealing member 114. The reduced-pressure interface 316 furtherincludes a cutting element 317.

The housing 354 may have a flange portion 360 and a cavity wall portion362. The cavity wall portion 362 forms a cavity 364 having atissue-facing cavity opening 366. The conduit port 356 is coupled to orformed as part of the cavity wall portion 362 of the housing 354. Theconduit port 356 includes a conduit aperture 368 whereby the conduitport 356 is adapted to receive the multi-lumen conduit 110. Theattachment device 152 may be coupled to a tissue-facing side 370 of theflange portion 360 for coupling the housing 354 to the first side 134 ofthe sealing member 114. The housing 354 is made of a semi-rigid materialthat is capable of collapsing under a force such as the driving force172. In a non-limiting example, the reduced-pressure interface 316, andthus the housing 354, may be made from a plasticized polyvinyl chloride(PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplasticelastomer, poly acrylic, silicone polymer, and polyether block amidecopolymer.

The cutting element 317 may be at least temporarily coupled to thehousing 354 proximate to the tissue-facing cavity opening 366. Thecutting element 317 is adapted to form an aperture 319 in the sealingmember 114 when the cutting element 317 is driven into the sealingmember 114 with the driving force 172. The driving force 172 may alsocause the cutting element 317 to penetrate or cut a portion of thedistribution manifold 112.

The cutting element 317 may have a piercing length (L_(p)). Thedistribution manifold 112 may have a thickness greater than T whensubject to reduced pressure such that the piercing length (L_(p)) of thecutting element 317 is less than the thickness T, i.e., L_(p)<T. Onebenefit of the piercing length (L_(p)) being less than the thickness, T,of the distribution manifold 112 under reduced pressure is that thecutting element 317 cannot completely cut through the distributionmanifold 112 and reach the tissue site 102.

As previously mentioned, the cutting element 317 may be only temporarilycoupled to the housing 354. In one embodiment, the cutting element 317may be removed by a care giver. In another embodiment, the cuttingelement 317 may be formed from a liquid soluble material such as a watersoluble material adapted to allow the cutting element 317 to dissolve.For example, the water soluble material may include at least one of thefollowing: Polyvinyl alcohol (PVOH), polyvinyl pyrrolidone, hydroxyl andcarboxyl modified cellulose, hydroxyl and carboxyl modified acrylics,starch, sugars (sucrose, glucose, fructose), weak acids (tartaric,citric, malic), salts (sodium chloride, sodium carbonate, sodiumbicarbonate), polyethylene oxide (PEO), polyethylene glycol (PEG). Thecutting element 317 may dissolve as liquids are removed from the tissuesite 102. Reduced pressure is applied to the reduced-pressure interface316 after perforating the sealing member 114 typically causing liquidsto be removed from the tissue site 102. After a sufficient amount oftime, liquids removed from the tissue site 102 cause the cutting element317 to substantially dissolve. The cutting element 317 may dissolvewithin 2 minutes, 5 minutes, 10 minutes, or another time period. As thecutting element 317 is dissolved the cutting element 317 is removed bythe multi-lumen conduit 110 with liquids from the tissue site 102. Aliquid, e.g., saline solution, may also be introduced through themulti-lumen conduit 110, or otherwise, to dissolve the cutting element317.

As shown in FIG. 7C, once the cutting element 317 has substantiallydissolved, reduced pressure applied through the reduced-pressureinterface 316 creates sufficient reduced pressure in the cavity 364 topull a portion of the distribution manifold 112 into the cavity 364 suchthat the distribution manifold 112 abuts a distal end 118 of themulti-lumen conduit 110 to include the distal aperture 176 of the atleast one of the plurality of sensing lumens 122. Allowing thedistribution manifold 112 to completely abut the distal end 118 of themulti-lumen conduit 110 may help ensure fluid isolation between each ofthe lumens in the multi-lumen conduit 110.

In operation, a caregiver may treat the tissue site 102 on the patient104 with a method that includes disposing the distribution manifold 112proximate to the tissue site 102. The distribution manifold 112 and theportion of intact epidermis 126 of the patient 104 is covered with thesealing member 114 to form the sealed space 132 in which thedistribution manifold 112 is disposed. The reduced-pressure interface316 is coupled to the sealing member 114. The multi-lumen conduit 110 isfluidly coupled on one end to the reduced-pressure source 146 and on theopposing end to the reduced-pressure interface 316. The driving force172 is then applied to the reduced-pressure interface 316 withsufficient strength to cause the cutting element 317 to perforate (e.g.,pierce, tear, cut or otherwise create the aperture 319) the sealingmember 114.

Referring now primarily to FIGS. 8-9C, another illustrative embodimentof a reduced-pressure interface 416 is presented. The reduced-pressureinterface 416 is analogous in many respects to the reduced-pressureinterface 316 of FIGS. 5A and 5B. The reduced-pressure interface 416includes a housing 454 and a cutting element 417. The housing 454 mayhave a flange portion 460 and a cavity wall portion 462. The flangeportion 460 may be coupled to the sealing member 114 by the attachmentdevice 152. The cavity wall portion 462 is collapsible under reducedpressure. The cavity wall portion 462 may include a bellowsconfiguration 490 for permitting the cavity wall portion 462 to collapsewhen a cavity pressure (P_(c)) inside a cavity 464 is less than athreshold pressure (P_(t)) on an absolute pressure side.

The reduced-pressure interface 416 may further include a conduit adapter492 for receiving the multi-lumen conduit 110 to provide fluidcommunication between the reduced-pressure treatment unit 108 and thetissue site 102. The conduit adapter 492 includes an adapter flange 494.The adapter flange 494 is positioned on an exterior 484 of the cavitywall portion 462. In a specific, non-limiting example, the conduitadapter 492 and the adapter flange 494 may be formed from materials toinclude plasticized polyvinyl chloride (PVC), polyurethane, cyclicolefin copolymer elastomer, thermoplastic elastomer, poly acrylic,silicone polymer, and polyether block amide copolymer.

The multi-lumen conduit 110 is connected to the conduit adapter 492. Ina specific, non-limiting embodiment, the multi-lumen conduit 110 may beconnected to the conduit adapter 492 by a weld or an adhesive. Themulti-lumen conduit 110 extends beyond the conduit adapter 492 into thecavity 464. The reduced-pressure interface 416 is configured to positionthe distal end 118 of the multi-lumen conduit 110 in contact with thedistribution manifold 112.

The cutting element 417 may be at least temporarily coupled to theconduit adapter 492. The cutting element 417 is configured to makeorthogonal cuts in the sealing member 114 when the housing 454 iscompressed with the driving force 172 thereby impacting the cuttingelement 417. The cutting element 417 is thus driven into the sealingmember 114. The driving force 172 may be manually applied to theexterior 484 of the reduced-pressure interface 416 causing the housing454 to collapse and thereby driving or pushing the cutting element 417into the sealing member 114. In another embodiment, the driving force172 is applied by applying reduced pressure to the cavity 464 such thatthe cavity pressure (P_(c)) in the cavity 464 is less than a thresholdpressure (P_(t)). When the cavity pressure (P_(c)) in the cavity 464 isless than the threshold pressure (P_(t)), the cavity wall portion 462collapses and impacts the cutting element 417. With continued reducedpressure, a portion of the cutting element 417 is driven through thesealing member 114. The threshold pressure (P_(t)) is at least in partdependent on the type and thickness of material used for the housing454. In the event reduced pressure is applied to the cavity 464, atensile force 473 may be applied to the sealing member 114 causing thesealing member 114 to be pulled into the cavity 464. This movement helpsthe cutting element 417 to be driven into the sealing member 114.

In one embodiment, the cutting element 417 may be formed from a liquidsoluble material such as a water soluble material adapted to allow thecutting element 417 to dissolve. The water soluble material may includeat least one of the following: Polyvinyl alcohol (PVOH), polyvinylpyrrolidone, hydroxyl and carboxyl modified cellulose, hydroxyl andcarboxyl modified acrylics, starch, sugars (sucrose, glucose, fructose),weak acids (tartaric, citric, malic), salts (sodium chloride, sodiumcarbonate, sodium bicarbonate), polyethylene oxide (PEO), polyethyleneglycol (PEG). The cutting element 417 may dissolve as liquids areremoved from the tissue site 102. Reduced pressure is applied to thereduced-pressure interface 416 typically causing liquids to be removedfrom the tissue site 102. After a sufficient amount of time, liquidsremoved from the tissue site 102 may cause the cutting element 417 tosubstantially dissolve. As the cutting element 417 is dissolved, thecutting element 417 is removed by the multi-lumen conduit 110 with theliquids from the tissue site 102. While the cutting element 417 may bedissolvable, it is worth noting that the conduit adapter 492 and theadapter flange 494 do not dissolve.

Once the cutting element 417 has substantially dissolved, reducedpressure applied through the reduced-pressure interface 416 may be ofsufficient reduced pressure in the cavity 464 to pull a portion of thedistribution manifold 112 into the cavity 464 and into contact with theprimary lumen 120 of the multi-lumen conduit 110. The distributionmanifold 112 abuts the distal end 118 of the multi-lumen conduit 110including the distal aperture 176 of the at least one of the pluralityof sensing lumens 122. Allowing the distribution manifold 112 tocompletely abut the distal end 118 of the multi-lumen conduit 110 mayhelp ensure fluid isolation between each of the lumens in themulti-lumen conduit 110.

Although the present invention and its advantages have been disclosed inthe context of certain illustrative, non-limiting embodiments, it shouldbe understood that various changes, substitutions, permutations, andalterations can be made without departing from the scope of theinvention as defined by the appended claims. It will be appreciated thatany feature that is described in connection to any one embodiment mayalso be applicable to any other embodiment.

It will be understood that the benefits and advantages described abovemay relate to one embodiment or may relate to several embodiments. Itwill further be understood that reference to ‘an’ item refers to one ormore of those items.

The steps of the methods described herein may be carried out in anysuitable order, or simultaneously where appropriate.

Where appropriate, aspects of any of the examples described above may becombined with aspects of any of the other examples described to formfurther examples having comparable or different properties andaddressing the same or different problems. It will be understood thatthe above description of preferred embodiments is given by way ofexample only and that various modifications may be made by those skilledin the art. The above specification, examples and data provide acomplete description of the structure and use of exemplary embodimentsof the invention. Although various embodiments of the invention havebeen described above with a certain degree of particularity, or withreference to one or more individual embodiments, those skilled in theart could make numerous alterations to the disclosed embodiments withoutdeparting from the scope of the claims.

We claim:
 1. A reduced-pressure connection, comprising: a distributionmanifold for placing proximate to a tissue site; a housing of semi-rigidmaterial; a conduit having a distal end and comprising at least onesensing lumen and at least one primary lumen; and wherein the distal endof the conduit is configured to be drawn into direct contact with thedistribution manifold.
 2. The reduced-pressure connection of claim 1,wherein the at least one sensing lumen is a plurality of sensing lumens,and wherein a plurality of distal openings are associated with theplurality of sensing lumens on the distal end of the conduit.
 3. Thereduced-pressure connection of claim 2, wherein the distal end of theconduit is in direct contact with the distribution manifold such that amajority of the plurality of distal openings abut the distributionmanifold.
 4. The reduced-pressure connection of claim 1, wherein thesemi-rigid material is selected from the group consisting of aplasticized polyvinyl chloride, polyurethane, cyclic olefin copolymerelastomer, thermoplastic elastomer, poly acrylic, silicone polymer, andpolyether block amide copolymer.
 5. A reduced-pressure interface,comprising: a housing forming a cavity adapted to collapse under reducedpressure; a conduit port coupled to the housing for receiving a conduitcomprising at least one sensing lumen configured to be drawn intocontact with a manifold; and an attachment device for coupling thereduced-pressure interface to a sealing member.
 6. The reduced-pressureinterface of claim 5, wherein the housing comprises a semi-rigidmaterial.
 7. The reduced-pressure interface of claim 6, wherein thesemi-rigid material is selected from the group consisting of aplasticized polyvinyl chloride, polyurethane, cyclic olefin copolymerelastomer, thermoplastic elastomer, poly acrylic, silicone polymer, andpolyether block amide copolymer.
 8. The reduced-pressure interface ofclaim 5, wherein the conduit comprises a primary lumen for deliveringreduced pressure and at least one sensing lumen.
 9. The reduced-pressureinterface of claim 8, wherein the conduit comprises a multi-lumenconduit.